Hedetus 5.4 mg/ml syrup
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Hedetus, 5.4 mg/ml, oral syrup
Dry extract of ivy leaf
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You must consult a doctor if you worsen or do not improve after 5 days.
Contents of this leaflet
- What Hedetus is and what it is used for
- What you need to know before taking Hedetus
- How to take Hedetus
- Possible side effects
- How to store Hedetus
- Contents of the pack and other information
1. What Hedetus is and what it is used for
Hedetus is a herbal medicine used as an expectorant in productive cough. It contains dried extract of ivy leaf (Hedera helix L., folium).
Hedetus is indicated for use in adults, adolescents, and children over 2 years of age.
You should consult a doctor if symptoms worsen or do not improve after 5 days.
2. What you need to know before starting to take Hedetus
Do not take this medicine:
- if you are allergic to ivy, other members of the Araliaceae family, or to any of the other components of this medicine (listed in section 6.1).
- in children under 2 years of age, as respiratory symptoms may generally worsen in this patient group.
Warnings and precautions
Consult your doctor before starting to take this medicine:
- if you have difficulty breathing, fever, or purulent sputum
- if symptoms persist for more than 5 days, or if you are using opioid antitussives such as codeine or dextromethorphan
- if you suffer from gastritis or gastric ulcer
Children
- Do not use in children under 2 years of age. See section "Do not take this medicine".
- If children between 2 and 4 years of age suffer from persistent or recurrent cough, a medical diagnosis will be required before starting treatment.
Taking Hedetus with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Hedetus with food, drinks and alcohol
No interactions with food, drinks or alcohol are known.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
It is recommended not to take Hedetus during pregnancy.
Breastfeeding
Hedetus should not be used during breastfeeding.
Fertility
There are no data available on fertility.
Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines.
Hedetus contains:
- 292.6 mg/ml sorbitol (E420). Sorbitol may have a mild laxative effect. Energy value 2.6 kcal/g sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
- 2.3 mg/ml lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
3. How to take Hedetus
Follow exactly the dosage instructions provided in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
Age | Dosage |
Adults, adolescents and elderly | 5 ml, 2 to 3 times daily |
Children between 6 and 12 years of age | 5 ml, twice daily |
Children between 2 and 5 years of age | 2.5 ml, twice daily |
Hedetus should be taken orally. The package contains a dosing cup to measure the correct dose.
There are insufficient data to make specific dosage recommendations in cases of renal/hepatic impairment.
If symptoms persist for more than 5 days of using the medication, you should consult your doctor.
If you take more Hedetus than you should
If you have taken more medication than you should have, consult your doctor or pharmacist immediately. Overdose of ivy leaf extract may cause nausea, vomiting, diarrhea, and nervousness. In case of poisoning or overdose symptoms, symptomatic treatment will be required.
If you forget to take Hedetus
Do not take a double dose to make up for missed doses.
If you stop taking Hedetus
Not applicable.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The following adverse effects have been reported (frequency unknown):
- Gastrointestinal disorders such as nausea, vomiting, or diarrhea.
- Hypersensitivity reactions, such as hives, skin rashes, difficulty breathing.
If you notice symptoms of hypersensitivity, stop taking Hedetus and consult your doctor.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Hedetus
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Once opened, the syrup expires after 28 days.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of any unused medicines and packaging. This will help protect the environment.
6. Package contents and other information
Composition of Hedetus:
The active substance is:
Dried extract of ivy leaf (Hedera helix L., folium). 1 ml of syrup (equivalent to 1.1 g) contains 5.4 mg of extract (in the form of dry extract) from Hedera helix L., folium (ivy leaf) (5-7.5:1). Extraction solvent: Ethanol 30% (m/m).
The other components are:
Monohydrate lactose, sorbitol (E420), benzoic acid (E210), xanthan gum, ammonium glycyrrhizinate, essential oil of Eucalyptus radiata (Sieber ex DC), and purified water.
Appearance of the medicine and contents of the container
Green, translucent liquid with a characteristic odour, in a 200 ml amber glass bottle with child-resistant plastic closure and a dosing cup.
Marketing Authorization Holder and Manufacturer
Conforma NV
Zenderstraat 10
9070 Destelbergen
Belgium
This medicine is authorized in the Member States of the European Economic Area under the following names:
BE: Pulmocap Hedera, siroop
NL: Pulmocap Hedera, stroop
LU: Pulmocap Hedera, sirop
FR: Hedetus, sirop
DE: Pulmocap Hedera, Sirup
PL: Mituret
IT: Edera Conforma
ES: Hedetus, jarabe
PT: Pulmocap Hedera, xarope
AT: Pulmocap Hedera, Sirup
Date of the most recent revision of this leaflet: 12/2017
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/